Ignite Creation Date:
2025-12-25 @ 4:53 AM
Ignite Modification Date:
2026-01-04 @ 8:38 AM
Study NCT ID:
NCT03674918
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2018-09-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Reliable Hypertension Diagnosis Based on 24 ABPM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 408}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2018-09-14', 'studyFirstSubmitQcDate': '2018-09-14', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Timing of measurement', 'timeFrame': 'day 1', 'description': '9:00-13:00 - 13:00-17:00 - 17:00 - 21:00: there intervals were analyzed to assess the predictive value of each interval compared with the overall daytime diagnosis of hypertension.'}], 'secondaryOutcomes': [{'measure': 'The correct number of measurements', 'timeFrame': 'day 1', 'description': 'Within the intervals, the correct number of measurements needed to diagnose hypertension will be evaluated.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Arterial Hypertension']}, 'descriptionModule': {'briefSummary': '24 h blood pressure monitoring can help to define which is the optimal timing and frequency of measurements', 'detailedDescription': "Hypertension is a common condition in modern society. As blood pressure fluctuates with time, a single blood pressure measurement is useless to diagnose hypertension. Nevertheless, a questionable not well-defined number of measurements still is often used for this purpose. Diagnosis and therapeutic control of hypertension are therefore suboptimal. This study's objective is to determine the number and timing of measurements needed to give a trustworthy approximation of an individual's average blood pressure. Therefore, 24 h ambulatory blood pressure measurements were retrospectively analyzed."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Arterial hypertension, HBPM, 24h ABPM, optimal diagnosis', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 70 per cent of valid measurements\n\nExclusion Criteria:\n\n* none'}, 'identificationModule': {'nctId': 'NCT03674918', 'briefTitle': 'Reliable Hypertension Diagnosis Based on 24 ABPM', 'organization': {'class': 'OTHER', 'fullName': 'Hasselt University'}, 'officialTitle': 'How to Reliably Diagnose Arterial Hypertension: Lessons From 24h Blood Pressure Monitoring.', 'orgStudyIdInfo': {'id': '24 ABPM001'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'persons with arterial hypertension', 'description': 'patients referred to consultation cardiology for hypertension. They get a 24 h blood pressure monitoring to define the exact mean arterial blood pressure', 'interventionNames': ['Diagnostic Test: 24 h ambulatory blood pressure measurements']}], 'interventions': [{'name': '24 h ambulatory blood pressure measurements', 'type': 'DIAGNOSTIC_TEST', 'description': '24 h ambulatory blood pressure measurements : an ambulatory 24 h blood pressure device that automatically measures blood pressure every 15 minutes is given to the patient for 24 h', 'armGroupLabels': ['persons with arterial hypertension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3500', 'city': 'Hasselt', 'country': 'Belgium', 'facility': 'Jessa Ziekenhuis', 'geoPoint': {'lat': 50.93106, 'lon': 5.33781}}], 'overallOfficials': [{'name': 'Caro Brenard, student', 'role': 'STUDY_CHAIR', 'affiliation': 'University of Leuven'}, {'name': 'Vincent Raymaekers, student', 'role': 'STUDY_CHAIR', 'affiliation': 'Universiteit Antwerpen'}, {'name': 'Paul Dendale, prof. dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hasselt University'}, {'name': 'Ines Frederix, dr. MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Hasselt University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hasselt University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Jessa Hospital', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'prof. dr. Paul Dendale', 'investigatorAffiliation': 'Hasselt University'}}}}